Kornimate/medical-research-clean huggingface dataset:
validating novel, non-contrast cardiac mri imaging in haemodialysis patients

Conditions: End Stage Kidney Disease; Fibrosis Myocardial

Summary: there are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac mri technique, called native t1 mapping, may provide a solution to this. to assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native t1 mapping to actual levels of scarring in the hearts of patients on dialysis.

native t1 mapping is a novel, non-contrast, cardiac mri technique that characterises myocardial tissue by exploiting the different water content of tissues. it correlates well with histo-pathological levels of myocardial fibrosis in diseases of pressure overload such as aortic stenosis. there is growing evidence to demonstrate the potential of native t1 mapping as an imaging biomarker of myocardial fibrosis in patients with esrd; myocardial native t1 values are higher in patients with esrd than controls, and associate with measures of myocardial strain and circulating markers of cardiac dysfunction. although native t1 times are affected by water content of tissues, our group has shown that native t1 times are not influenced by clinical changes in fluid status in hd patients and that the inter-study reproducibility and intra- and inter-observer variability of native t1 are outstanding. native t1 mapping is a promising, non-invasive imaging biomarker of myocardial fibrosis in patients with advanced renal disease. it is essential that the technique is validated against histology before further use in clinical studies. the aim of this study is to directly assess the relationship between native t1 mapping and levels of mf examined at post-mortem in haemodialysis patients.

Eligibility criteria:
inclusion criteria: * prevalent haemodialysis patient (more than 3 months) * active on the supportive care register with anticipated death in the subsequent 12 months * able to give informed consent * consent to donation of heart for research following death * able to understand written and verbal explanations in english exclusion criteria: * contraindication to mri scan (e.g. pacemaker, incompatible metallic implants, claustrophobia) * patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis) * unable to give informed consent * unable to understand written and verbal explanations in english

Keywords: cardiac mri hemodialysis myocardial fibrosis myocardial inflammation
retrospective analysis of the efficiency of caplacizumab in the treatment of attp

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Summary: the objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in ittp-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. the rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura * treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.) * male or female patients ≥ 18 years of age * signed written informed consent exclusion criteria: * hereditary thrombotic thrombocytopenic purpura * disability to give informed consent

Keywords: attp caplacizumab
teachable moment to opt-out of tobacco: interactive voice response quit line for veteran active smokers with lung nodules

Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Tobacco Use

Summary: the purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (team out) on increasing use of smoking cessation resources in veterans. the hypotheses are 1) patients included in the team out group will have higher accession of cessation services, such as counseling and medication therapies, compared to patients in enhanced usual care and 2) more patients in the team out group will have quit smoking at one year after the intervention. veterans with a recently diagnosed lung nodule who currently smoke will receive the team out intervention or enhanced usual care. the team out intervention has 2 parts: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a proactive ivr quit line will initiate contact and 2) call(s) from the proactive ivr quit line which a) offers smoking cessation resources and b) helps connect the patient to those resources. the enhanced usual care group will receive a letter that provides information about how to contact the ivr quit line. the ivr system will track referrals to cessation services. additional information about smoking status and use of cessation resources will be collected from the electronic health record and surveys. .


Eligibility criteria:
inclusion criteria: * newly diagnosed pulmonary nodule with plan for surveillance * active smoker * receiving care at the portland va health care system, the minneapolis va health care system, or the ralph h. johnson medical center (charleston, sc va) exclusion criteria: -no exclusion criteria

Keywords: tobacco use cessation smoking evaluation study
a study of c-kit mutation as mrd in acute myeloid leukemia

Conditions: C-KIT Mutation

Summary: c-kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. however, the clinical significance of c-kit mutation as molecular mrd monitoring is still unclear. what are the differences and advantages of using c-kit mutation as mrd in prognostic assessment compared with other mrds (mfc or runx1::runx1t1) widely used today? existing data suggest that patients with one positive and one negative mrd results obtained by two different techniques have a higher risk of recurrence than patients with two negative mrd results but a lower risk of recurrence than patients with two positive mrd results. therefore, can combining multiple mrd markers, including c-kit mutations, overcome the shortcomings of a single molecular marker as mrd monitoring? therefore, this project intends to confirm the clinical significance of quantitative detection of c-kit mutation as mrd in acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: patients who meet the diagnostic criteria(who 2016 criteria) of aml and have c-kit d816 mutation. and receive treatment. exclusion criteria: patients with other factors which were considered unsuitable to participate in the study by the investigators

Keywords: acute myeloid leukemia c-kit mutation mrd
effects of a combined supplementation of conjugated linoleic acid (cla) and probiotics (vivomixx®) as add-on to a first-line immunotherapy in relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (dmt, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting ms (rrms). 100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (dmt). the two randomized groups will be compared concerning the change in volume of t2-weighted hyperintense lesions from baseline to 48 weeks.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis according to current mcdonald criteria, edss maximal 5.5, 18-60 years * stable treatment with first-line dmt (ifnbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months * absence of a clinical relapse for at least 3 months before inclusion * written informed consent exclusion criteria: * diagnosis of primary or secondary progressive ms or other active autoimmune disease * intake/administration of the following disease modifying therapies: 1. at any time point: alemtuzumab, cladribine 2. during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod 3. during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab * ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids) * significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions) * accompanying systemic immunosuppressive treatment * relevant dietary restriction (e.g. strictly vegan nutrition) * women during pregnancy or lactation
photobiomodulation in dry age related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the goal of this clinical trial is to evaluate effects of consecutive yellow and red light emitting diode photobiomodulation in dry age-related macular degeneration (amd). the main questions it aims to answer are: * is yellow and red light emitting diode photobiomodulation effective in decreasing drusen volume in patients affected by dry amd? * does yellow and red light emitting diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry amd? participants will be randomly assigned to a treatment or a sham group. treatment consists in two cycles with two phases each: * 1st phase: 300 seconds of continuous yellow light with eyes closed + 60 seconds of pulsed yellow light with eyes opened; * 2d phase: 300 seconds of continuous red light with eyes closed + 60 seconds of pulsed red light with eyes opened. cycle 1 consists of 8 sessions (two pbm per week for 4 weeks) and cycle 2 consists of 6 sessions (two pbm per week for 3 weeks). researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry amd.


Eligibility criteria:
inclusion criteria: * bcva etdrs \> 40 l etdrs at 4 meters * diagnosis of dry amd areds grade 2-3 * ability to communicate well with the investigator and able to understand and comply with the requirements of the study exclusion criteria: * concomitant epilepsy * neurological diseases * psychiatric pathologies * herpes virus infections * dense cataract * pregnancy * other significant ocular and/or retinal diseases

Keywords: age related macular degeneration photobiomodulation
partially covered and uncovered metal stent for malignant distal biliary stricture

Conditions: Malignant Distal Biliary Stricture

Summary: endoscopic retrograde biliary drainage with a self-expandable metal stent (sems) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. with potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy. although semss have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. it has been widely accepted that covered semss designed to overcome the stent failure of uncovered semss related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. therefore covered semss did not show the clear clinical excellence in the cumulative stent patency over uncovered semss, despite some clinical results of randomized trials favor to covered semss. from the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. it was initially assumed that covered semss could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. however, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered semss in several randomized trials and meta-analysis. the aim of the current study is to compare the cumulative stent patency of partially covered and uncovered sems as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.


Eligibility criteria:
inclusion criteria: 1. \> 20 years 2. malignant biliary obstruction, 2 cm distal to hilum 3. unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal 4. expected survival \> 4 months based on karnofsky performance score. exclusion criteria: 1. history of biliary surgery except cholecystectomy 2. history of sems placement 3. coagulopathy (inr\>1.5, platelet\<50000) 4. duodenal stricture
a study to evaluate the difference in ipad-based cognitive video game (akili interactive's project: evo) performance in amyloid-positive versus amyloid-negative healthy elderly volunteers

Conditions: Healthy

Summary: the purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an ipad video game (akili interactive's project: evo) in healthy elderly volunteers based on amyloid status.


Eligibility criteria:
inclusion criteria: * healthy males and females between the ages of 70 and 80. * subjects must have bmi of 17.5 to 32 kg/m2 and total body weight \> 110 pounds. * acceptable screening mri and pet scans that pass quality control requirements. exclusion criteria: * co-morbid diagnosis of clinically documented alzheimer's disease; - significant cognitive impairment; * mmse (mini mental state examination) score \<26

Keywords: healthy elderly volunteers
prophylactic antipyretic treatment in children receiving pneumococcal conjugate and standard infant vaccines

Conditions: Infections, Rotavirus

Summary: the purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.

2 groups (200 per group); control group receives no prophylactic antipyretic treatment.

Eligibility criteria:
inclusion criteria: * healthy children 9-16 weeks old and born after a gestation of at least 36 weeks. exclusion criteria: * body weight \< 4.5 kg * children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs * children with any disease that affects the immune system or gastro-intestinal tract * children with a history of seizures, allergic disease, or disease(s) covered by the vaccines * children with contraindication to paracetamol treatment.

Keywords: pneumococcal disease
project leah: learning to eat at home

Conditions: Autism Spectrum Disorder; Feeding Behavior

Summary: the investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible.

the investigators hope to recruit 10 participants who have a diagnosis of autism spectrum disorder and food selectivity. a multidisciplinary feeding assessment will be conducted and factors which contribute to the participant's feeding challenges will be identified. treatment goals will be identified using the canadian occupational performance measure (copm). intervention geared to address the goals identified by parents will be delivered by the clinician(s) via videoconferencing. participants will participate in up to 12 weekly 1hr visits over the study period.

Eligibility criteria:
inclusion criteria: * age: 2-5 years of age * diagnosed with autism spectrum disorder * history of mild to moderate food selectivity * access to internet service * access to a windows based laptop with a web camera * one parent is available to participate in a 1 hour intervention program within the home environment once per week over a 12 week period. * english speaking participants * parent consents to use of ontario telemedicine network (otn) technology within in the home. * parent is able to use a laptop * access to a telephone in order to trouble shoot problems that may arise in setting up otn technology. exclusion criteria: * age: \> 6 year of age (rationale being most children will be enrolled in school during the week thus not available for intervention services). * history of severe food selectivity * no access to internet service and/or laptop * history of dysphagia or other swallowing difficulties * oro-motor abnormalities such as cleft lip and palate, macroglossia * presently has a g-tube insitu * participants on medications that may significantly alter appetite such as stimulants and antipsychotic medications. * currently enrolled in a feeding intervention program.
diaphragm injury and dysfunction during mechanical ventilation

Conditions: Respiratory Insufficiency; Diaphragm Injury; Mechanical Ventilation Complication

Summary: this study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (vidd). diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.

multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation. the objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. to address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation. diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. diaphragm structure is assessed by daily ultrasound imaging. study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).

Eligibility criteria:
inclusion criteria: * adult patients (\>18) with acute respiratory failure receiving invasive mechanical ventilation for less than 36 hours diagnosed with any of the following conditions: acute severe brain injury; moderate or severe ards; septic shock; pneumonia exclusion criteria: * predicted probability of remaining alive and on the ventilator on icu day 7 is less than 50% * liberation from mechanical ventilation is expected/planned within 24 hours * high cervical spine injury (c5 or higher) * receiving mechanical ventilation for neuromuscular disease * acute exacerbation of an obstructive lung disease * known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe * esophageal, gastric or duodenal surgical procedures within the last 6 months * received mechanical ventilation for \> 48 hours in the preceding 6 months

Keywords: diaphragm dysfunction acute respiratory failure weaning
eribulin mesylate in treating patients with advanced or recurrent cervical cancer

Conditions: Recurrent Cervical Cancer; Stage IIIA Cervical Cancer; Stage IIIB Cervical Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer

Summary: this phase ii trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical cancer. drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

primary objectives: i. to evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival \[pfs\]. secondary objectives: i. to describe the toxicity profile of eribulin in patients with advanced or recurrent cervical cancer. ii. to estimate the survival of patients with advanced or recurrent cervical cancer treated with eribulin. iii. to evaluate potential correlative studies as predictive or prognostic makers in this patient population (glucose-regulated protein 78 \[grp78\] levels in tissue and blood, tumor protein p53 \[p53\] expression, apoptosis with terminal deoxynucleotidyl transferase dutp nick end labeling \[tunel\] assay, apoptosis-related proteins b-cell lymphoma 2 \[bcl-2\] and bcl2-associated x protein \[bax\] using immunohistochemistry \[ihc\], proliferation with ki-67 ihc, and expression levels of microtubule-associated variables, including tau protein, total alpha- and beta-tubulin, and classes ii-iv beta-tubulin isotopes with ihc. outline: patients receive eribulin mesylate 1.4 mg/m2 intravenously (iv) bolus over 2-5 minutes on days 1 and 8. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up every 3 months for 2 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of invasive cervical cancer * measurable disease * 0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy * absolute granulocyte count (agc) \>= 1,500 * platelet \>= 100,000 * serum creatinine \< 2.0 mg/dl * bilirubin =\< 1.5 times the upper limit of the normal range (uln) * alkaline phosphatase =\< 3 x uln (in the case of liver metastases, =\< 5 x uln) * alanine aminotransferase (alt) and aspartate aminotransferase (ast) =\< 3 x uln (in the case of liver metastases, =\< 5 x uln) * peripheral neuropathy grade 0-2 * recovery of all chemotherapy or radiation-related toxicities to grade =\< 1, except for alopecia and peripheral neuropathy * performance status 0-2 * signed informed consent exclusion criteria: * prior treatment with eribulin * chemotherapy, radiation, or biological or targeted therapy within 3 weeks * hormonal therapy within 1 week * any investigational drug within 4 weeks * known brain metastases, unless previously treated and asymptomatic for 3 months and not progressive in size or number for 3 months